Thermo Fisher Scientific
Job ID :
US - California - Carlsbad
Assist with a wide variety of inspections, checks and sampling procedures for purchased products. Create Certificate of Analysis and audit or proof specification sheets. This individual should be able to understand and execute testing processes as defined in work instructions or standard operating procedures with limited supervision or guidance.
We are seeking a self-motivated individual with strong communication and operational skills to perform daily tests. This individual will coordinate these activities to ensure they are completed in an efficient manner and key customer expectations are met on time and in full. Candidate must be able to work independently, as well as on teams. Must have the ability to multitask in a fast-paced environment and prioritize work as necessary.
* Provide quality support through timely inspection / verification of materials, processes and products to confirm compliance with specifications.
* Responsible for incoming raw material verification and release.
* Prepare monthly metrics for review by Quality Supervisor as required.
* Identify and implement opportunities for improvement across the operational facility.
* Utilize the Trackwise system for nonconformances, deviations, Corrective and Preventative actions (CAPA).
* Utilization of Agile system to document change control
* Compile inspection records, approved COC/ CofA to facilitate traceability for demonstration of product compliance
* Retrieve manufacturing test/calibration data. Ensure appropriateness and completion of inspection documentation as follows:
* Test Results are within specifications
* COA / COC are prepared and signed
* Good Documentation Practice
* Perform product / process acceptance activities based on approved and released specifications and documentation as define in respective process SOP.
* Ensure that systems and procedures are in compliance with ISO9001 and site procedures
* Approve raw material and incoming specification documents (SPC's)
* Interacts with cross functional internal customers for resolution of issues
* Support plant-wide activities and special projects, as assigned.
* 3 years of related work experience in quality assurance, quality control, compliance, document control or equivalent.
* Working knowledge of ISO 9001, ISO 13485 standards a plus
* Quality Assurance experience highly desired
* Ability to work independently or as part of a team, self-motivated, adaptable
* Excellent communication and attention to detail
* Project management experience with solution based involvement
* Ability to troubleshoot and identify corrective actions
* Ability and experience implementing solutions
* Work with management on process improvements
* Science education preferred
* Working knowledge of ISO requirements
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global provider of laboratory products and services, life science solutions, analytical instruments, and specialty diagnostics.